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S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy (SOHUG)

Primary Purpose

Stomach Cancer

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
S-1 (452500ACH)
OXALIPLATIN (205803BIJ)
Sponsored by
Kangbuk Samsung Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Cancer focused on measuring Stomach Cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who voluntarily provide written informed consent prior to entering into this study
  • Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically
  • Patients who underwent radical resection with wide lymph node dissection
  • TNM stage (6th AJCC) of IIIB or IV on post-operative staging
  • Patients who can be randomized within 6 weeks after surgery

Exclusion Criteria:

  • Aged < 20 years or ≥ 76 years
  • Eastern Cooperative Oncology Group (ECOG) performance status >2
  • Patients who underwent surgery for neoplasm in stomach in the past
  • History of malignant disease The following cases can be included in this study - adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ
  • Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1) including distant lymph node (behind the pancreas, along the aorta, portal vein, behind the peritoneum, mesenteric lymph node)
  • Residual cancer on post-operative staging (R1 and R2 resection)
  • Patients who received adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer
  • Any of the following within 6 months prior to the study recruitment: Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, serious cardiac arrhythmia requiring treatment
  • Patients of childbearing potential who do not agree to use generally accepted effective method of birth control during the study treatment period and for at least 6 months after the end of study treatment
  • Pregnant women, breastfeeding women, or women of childbearing potential whose pregnancy test result is positive•
  • History of hypersensitivity to the investigational products (S1 and Oxaliplatin)

Sites / Locations

  • Kangbuk Samsung Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S-1/Oxaliplatin

Arm Description

S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months; Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months

Outcomes

Primary Outcome Measures

3-year recurrence-free survival, RFS

Secondary Outcome Measures

5-year overall survival, OS

Full Information

First Posted
June 23, 2014
Last Updated
December 6, 2022
Sponsor
Kangbuk Samsung Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02191566
Brief Title
S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy
Acronym
SOHUG
Official Title
A Phase II Study of Adjuvant Chemotherapy of S-1 With Oxaliplatin in Gastric Cancer at Stage IIIB/ IV (AJCC 6th) After D2 Resection
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
The patient's study enrollment was too low.
Study Start Date
May 2015 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kangbuk Samsung Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
After curative resection, patients with stage IIIB-IV (M0) gastric cancer were given chemotherapy as follows: S-1 orally at 80 mg/m2 divided in two daily doses for 14 days and oxaliplatin at 130 mg/m2 intravenously over 2 h every 21 days as one cycle. S1 was administered for 16 cycles (12 months) and oxaliplatin for 8 cycles (6 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Cancer
Keywords
Stomach Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S-1/Oxaliplatin
Arm Type
Experimental
Arm Description
S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months; Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months
Intervention Type
Drug
Intervention Name(s)
S-1 (452500ACH)
Other Intervention Name(s)
TS-1 (tegafur+gimeracil+oteracil)
Intervention Description
S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months
Intervention Type
Drug
Intervention Name(s)
OXALIPLATIN (205803BIJ)
Other Intervention Name(s)
PLEOXTIN (645402430)
Intervention Description
Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months
Primary Outcome Measure Information:
Title
3-year recurrence-free survival, RFS
Time Frame
3-year
Secondary Outcome Measure Information:
Title
5-year overall survival, OS
Time Frame
5-year
Other Pre-specified Outcome Measures:
Title
Toxicity will be graded according to the CTCAE.
Description
For patients who have experienced a dosing delay for starting treatment cycle, all assessments will be performed as scheduled. Reasons for dose modifications or delays, the supportive measures taken, and the outcome will be documented in the patient's chart and recorded in the CRF.
Time Frame
1-year
Title
compliance for chemotherapy
Description
Accountability and subject compliance will be assessed by maintaining adequate dose of S1 and return records. Subjects will be asked to return all used and unused drug supply containers at the end of each cycle as a measure of compliance. The clinical administration records will be used to monitor compliance with oxaliplatin.
Time Frame
1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who voluntarily provide written informed consent prior to entering into this study Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically Patients who underwent radical resection with wide lymph node dissection TNM stage (6th AJCC) of IIIB or IV on post-operative staging Patients who can be randomized within 6 weeks after surgery Exclusion Criteria: Aged < 20 years or ≥ 76 years Eastern Cooperative Oncology Group (ECOG) performance status >2 Patients who underwent surgery for neoplasm in stomach in the past History of malignant disease The following cases can be included in this study - adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1) including distant lymph node (behind the pancreas, along the aorta, portal vein, behind the peritoneum, mesenteric lymph node) Residual cancer on post-operative staging (R1 and R2 resection) Patients who received adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer Any of the following within 6 months prior to the study recruitment: Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, serious cardiac arrhythmia requiring treatment Patients of childbearing potential who do not agree to use generally accepted effective method of birth control during the study treatment period and for at least 6 months after the end of study treatment Pregnant women, breastfeeding women, or women of childbearing potential whose pregnancy test result is positive• History of hypersensitivity to the investigational products (S1 and Oxaliplatin)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Hoe Koo, MD,PhD
Organizational Affiliation
Kangbuk Samsung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22010012
Citation
Sasako M, Sakuramoto S, Katai H, Kinoshita T, Furukawa H, Yamaguchi T, Nashimoto A, Fujii M, Nakajima T, Ohashi Y. Five-year outcomes of a randomized phase III trial comparing adjuvant chemotherapy with S-1 versus surgery alone in stage II or III gastric cancer. J Clin Oncol. 2011 Nov 20;29(33):4387-93. doi: 10.1200/JCO.2011.36.5908. Epub 2011 Oct 17.
Results Reference
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PubMed Identifier
22226517
Citation
Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzen F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7.
Results Reference
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PubMed Identifier
20734110
Citation
Lee SS, Jeung HC, Chung HC, Noh SH, Hyung WJ, Ahn JY, Rha SY. A pilot study of S-1 plus cisplatin versus 5-fluorouracil plus cisplatin for postoperative chemotherapy in histological stage IIIB-IV (M0) gastric cancer. Invest New Drugs. 2012 Feb;30(1):357-63. doi: 10.1007/s10637-010-9515-2. Epub 2010 Aug 24.
Results Reference
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S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy

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